Sustainable Management Practices to Include Mixtures of Chemicals in Regulatory Approaches Focusing on the Global South

Abstract

Environmental pollution is becoming increasingly unpredictable over time due to its complexity, given the number of new chemicals produced annually and the constantly changing environmental conditions. Regulation has yet to keep pace with the rapid changes posed by chemical mixtures, especially in the Global South. Understanding the potential outcomes of co-exposure to multiple compounds can be challenging, even for professionals with a background in sustainability and mixture toxicity, due to the complexity of the issue. Some tools have been developed to tackle this uncertainty like the Species Sensitivity Distribution curve (SSD), the Adverse Outcome Pathways (AOP), and the Mixture Assessment Factor (MAF). This study aims to bridge the gap between knowledge generated in the field of mixture toxicity and regulatory practices by proposing sustainable management practices at the local scale, particularly for countries in the Global South. The proposed framework is called GlORIES and comprises the following measures. The first proposed step is to describe the chemicals used in industries or identified in existing environmental studies and/or monitoring campaigns on a watershed basis. Having a watchlist of compounds and organisms present in the region, and by generating a regionalized SSD, it is possible to use models such as AOPs to try to predict which compounds could potentially interact and thus generate a correcting factor, such as a MAF. A MAF could then be incorporated into regulations to further protect the environment by reducing the concentration of the compound in the mixture. Including local communities in reporting human and environmental health alterations could be a key to identifying the possible harmful emissions. It is proposed that watershed management committees be established to integrate all stakeholders and promote workshops organized by academia, industry, regulatory agencies, and civil society, leveraging existing structures to conserve energy in the process. The proposed framework can improve the sustainability of the process and the knowledge flow from academia to regulatory bodies, increasing the efficacy of the chosen water quality thresholds by adapting to real-life scenarios.

1. Introduction

Regulatory practices often are responsible for maintaining environmental concentrations of hazardous chemicals of concern below the threshold of significant effect, usually concentrations at which no effect was observed, such as the No Observed Adverse Effect Level (NOAEL), No Observed Adverse Effect Concentration (NOAEC), and Benchmark dose [1]. These policy thresholds regarding new tests for new compounds or effluents from specific activities are established by performing literature research on the subject to make a data-based and robust decision on the limits for each particular compound [1,2]. Different effects and species tested can be standardized, such as soil and water organisms [3,4,5,6,7] for environmental concentrations and in vitro testing for human exposure, to provide the ideal concentrations based on actual effects observed, such as disturbances in the standardized endpoints [8].

Occurring in all environmental compartments, chemicals can have multiple co-occurring exposure routes to both humans and the ecosystem; therefore, all relevant chemicals should be evaluated for their possible adverse effects on the biota. The primary concern is the number of chemicals being generated and their complexity when combined with naturally occurring and other pollutants in the environment, particularly in regions where regular environmental monitoring of chemicals is not conducted due to resource constraints [9]. Mixtures of chemicals present in the environment are a threat to seven out of the 17 UN sustainability development goals such as (3) good health and well-being, (6) clear water and sanitation, (11) sustainable cities and communities, (12) responsible consumption and production, (13) climate action, (14) life below water, and (15) life on land.

A shift in approach has been noted to consider the effect of the mixture itself in the regulatory assessment due to possible interactions between the compounds of each mixture, because of possible synergistic or antagonistic effects (observed effects greater than and smaller than the additive effects, respectively) [1,10]. Although mixture toxicity has been researched for a few decades, it has already been demonstrated that the concentrations of isolated compounds do not accurately represent what may be occurring in the natural environment. Thus, the importance of connecting what is being produced in academia with the regulatory practices is indisputable as a means of connecting the knowledge produced by both ends, academia, and regulatory bodies, and optimizing their outcomes by saving efforts for what has already been produced [2].

Different methods have been employed to evaluate various mixtures in risk assessment, aiming to enhance confidence in the safety values provided by legislation. It is possible to demonstrate the importance of sustainable environmental regulation frameworks that can protect the environment while also allowing reference values to be updated after new information has been acquired through the application of different computational methods, consultation of existing literature, or publication of new toxicological data. Despite substantial development, regulatory agencies remain skeptical about embracing new technologies to update their accepted environmental concentrations, sometimes referred to as regulatory accepted concentrations (RACs) [11]. A few challenges delay mixture risk assessment from being fully applied such as the novelty factor; overlapping regulatory silos [1]; data gaps in the risk/toxicity/mode of action (MoA) of specific compounds and mixtures [10,11]; different levels of knowledge on exposure, impacts and governance in other regions of the world [12]; and a comprehensive assessment of the uncertainties associated with mixtures and the communication of these uncertainties with policymakers.

Amongst these challenges, the data gaps on the mixture toxicity of pollutants exist due to the exponential and almost infinite number of mixtures possible and the lack of continuous and reliable monitoring, especially in the Global South countries, in which data are not often readily available as opposed to the Global North monitoring databases [9,13]. Given that time and resources are limited, the mixture risk assessment should be more widely utilized as a trustworthy methodology for evaluating the potential effects of pollutants. A problem arises from this approach as the amount of data required as input for the model increases with its complexity, thus being perfectly applicable in data-rich regions while applied with some constraints due to lack of data in the Global South [2,13]. Data-driven solutions point toward a strategy including all involved stakeholders: academia, regulatory agencies, and industry [12,14]. It could be possible to manage the risks by regulating and prioritizing mixtures of concern, and then modeling and testing them to update regulations [15].

Around the world, various approaches are implemented for chemical regulation, but overlapping competencies are standard in most countries [1]. Different organizations often regulate human health, environmental quality, agriculture, and mining, and if integrated, their efforts could provide a holistic understanding of the effects observed in humans and the environment [1]. However, regulation tends to lack procedural promptness in incorporating New Approach Methodologies (NAMs), which are often elaborated upon by academics through scientific publications [14].

Due to the extensive effort required to model all compounds and their respective combinations, the current work aims to bridge the gap between mixture toxicity modeling techniques and current watershed/regional water management practices through predictive indirect methods and effluent toxicity evaluation. This paper will first present the entire proposed sustainable framework and then elaborate on each route separately.

2. Methodology

This paper proposes a framework to help better integrate academia, industry, regulatory agencies, and civil society by providing comprehensible and easy-to-follow guidelines to promote integration and a more efficient knowledge flow between all stakeholders. The frameworks were developed by a literature review and were performed using the methodology described below.

To understand the current scenario, the keywords researched on SCOPUS, Web of Science, and Google Scholar were “regulatory toxicology”, “water quality thresholds”, “watershed management”, “environmental impact study”, and “effluent toxicity”. The period evaluated spanned the last 20 years of data, from 2004 to 2024. The inclusion criteria were papers, guidelines, and official regulatory documents referring to water management methodologies, toxicity evaluation methods, and environmental management practices. Exclusion criteria were papers, guidelines, and methodologies concerning soil and air quality, as the focus of this work is the regulation of aquatic ecosystems.

Evaluation criteria were established for the selected papers, and they are:

Similarity: The papers were evaluated for their similarity with each other, focusing on those ideas that might be repeated worldwide.

Applicability: Papers with simpler and direct ideas were considered more applicable and thus were given preference when listing the possible reference models for the presented framework.

Relevance: Highly cited papers or guidelines from consolidated organizations were considered highly relevant due to their impact. Organizations such as the World Health Organization (WHO), the United Nations (UN), and the European Commission were deemed “high relevance”.

Scope: Papers concerning methodologies for mixture toxicity evaluation in water were deemed of high importance, while papers that discussed the water quality of single compounds were classified as medium importance.

Reach: The breadth of the methodologies in terms of area was also considered, and papers discussing watershed management practices were deemed of high importance, as the proposed framework aims to work locally.

With the data gathered from this literature review, it is possible to comprehend the measures being taken worldwide regarding water quality threshold updating processes, as well as different modeling techniques for the toxicological evaluation of mixtures that could be applied to different regulatory scenarios. As a result of this analysis, we propose a new framework for updating the regulatory threshold for water quality, primarily intended for use by regulators. Still, it could also be used by civil society to provide a bird’s-eye view, allowing them to understand the process better, identify areas where they can act, and determine which stakeholders to contact when needed. It is essential to note that any validation processes involving regulators are outside the scope of this work; further work will be required to validate the applicability and scalability of the results.

3. Results and Discussion

3.1. Proposed Framework

Criteria were established to guide the process and ensure its utility for regulators, civil society, and industry. The main principles of the framework give its name as GlORIES: (i) Global South-centered; (ii) Open access data generated on the watershed as a means for environmental protection; (iii) Regionalization of the information to the watershed level since surface water contamination occurs usually through treated/untreated effluent discharge; (iv) Integration between different forms of knowledge produced in academia, industry, regulatory bodies, and civil society; and (v) the “Energy Saving principle” meaning that groups and discussions established on the local scale could be used as “polinizers” for the framework and thus saving the energy that was already dedicated in creating these connections with local communities and increasing the sustainability of the process.

3.1.1. Principles

Global South-Centered

Due to extensive monitoring, the Global North has a bigger database from which it is possible to elaborate trustworthy models and thus sound regulation [9]. However, the reduced size of monitoring data in the Global South means that using the same models applied with extensive data on countries with less data available might lack robustness. The Global North and South have different environmental characteristics, including temperature, humidity, rainfall, climate, biomes, land use, and occupation. While the efforts towards harmonization are intense, there are limits to any model, especially when input data are scarce.

Creating a Global South-centered framework entails generating the necessary data for safe and reliable regulation, while guiding local governments on how to utilize it effectively. Recognizing the knowledge generated in the Global South as trustworthy and applicable is also one way to alter the flow of knowledge, fully including local stakeholders, which means trusting local information.

Open Access

Data availability is crucial for cheaper methodologies since paying for input data to any proposed environmental model would not be necessary. Governmental information on environmental quality, if generated with public funds, should already return to society as open data. However, private organizations that generate and manage wastewater must present their characteristics, such as physicochemical parameters and toxicity results, to regulatory agencies. Thus, these data are typically not available in open access. Data from environmental studies are also available when consulting the regulatory agencies. However, they are not always open access. It is necessary to use these data, which usually demands extra steps, such as providing a reasoning for the use and evaluation of the provided data. As examples of this suggestion, there is the NORMAN database system, which is a “network of reference laboratories, research centers, and related organizations for monitoring of emerging environmental substances” that compiles monitoring data and facilitates its reach [16]. NORMAN provides environmental monitoring data for indoor air quality, surface water quality, food and safety, which are available as open-source information.

It is comprehensible that sensitive data should be protected from the public. However, access to the environmental quality of surface water could be simplified. Therefore, organizing data that has already been generated periodically in an open database could help civil society and regulatory agencies understand what information the general public demands after access is established. A given community, when given access to effluent toxicity data, could learn that their water has a high pollutant concentration and demand extra care from their local regulatory agency. This principle empowers civil society by providing them with information on the workings of industries in the region, thereby gaining the trust of communities while enabling academia and regulatory agencies to implement more precise environmental protection measures.

Regionalization

Regulating using published papers to verify the toxicity of a given compound is a method that favors environmental protection while having a scientific basis. However, biota and environmental conditions vary regionally, and regulations are being developed using standardized organisms, such as Daphnia magna, which are commonly found in temperate climates. Those organisms might not accurately reflect the local pollution dynamics of several countries in the Global South. Thus, local regulatory agencies could benefit from the local data generated, either from the presence of local species or the characteristics of the effluent. After creating an open database based on the previous principle, consultation on information at the watershed level may be available. Perception of the pollutants present in the watershed can help predict their effects on the local biota.

Integration

Academia, industry, regulatory bodies, and civil society all benefit from exchanging information on environmental protection, whether it involves industry and civil society consuming resources at a sustainable pace for the long term or regulatory bodies and the academy promoting informed decisions [17]. When information is kept behind paywalls or literal walls, in the case of environmental studies that are only accessible in situ, it is not only cost-ineffective but also a waste of time and effort that was put into generating and using the information less optimally [18]. The benefits from integration could stem from conversations between stakeholders, where instead of trying to find the responsible party for a given problem, they work together to find possible solutions.

Energy Saving Principle

This framework acknowledges the efforts made by various organizations towards a safer environment and, therefore, seeks to incorporate them into the process, thereby saving the energy required to develop this methodology from the outset. The energy for the framework would be saved using methods already in place, such as Adverse Outcome Pathways (AOPs) and organizations like watershed management committees. The process of creating a network of reliable contributors is long and usually demands long meetings over the course of several months, all processes already performed by the local management communities. By partnering with pre-established organizations it is possible to save time and resources it would take to develop this new network.

Watershed management committees are established in various countries worldwide and typically include all relevant stakeholders regarding water use, including quantity and quality. Pairing with an important organization that shares bonds with local communities, the framework would be implemented through workshops to empower local agents to become pollinators of the presented ideas. Thus, it would be necessary to form a scientific council that would be integrated into each committee and generate a way to implement the framework for the local reality.

3.1.2. Framework Graphical Representation

In Figure 1, the authors propose a new approach to updating regulations regarding chemical mixtures, which are divided into three main routes: chemical, biological, and social. This classification can help policymakers by highlighting essential steps in the process, such as including all affected parties in the analysis and remembering how other species are affected by the chemicals in the water. The method could also be extended to include climate change, as it is flexible enough to accommodate stressors other than chemical ones. Three routes are proposed: chemical, biological, and social.

Figure 1. Schematic representation of the proposed framework GlORIES.

3.1.3. Scale

To simplify the analysis, the proposed framework uses the watershed as the management scale, as it is the geographical boundary in which the surface water carries most of its pollutants. By separating each watershed as management hotspots, it is easier to engage the population, as some countries already have surface water management practices, with a watershed committee comprising the affected parties: regulation, industries, and civil society [19]. Therefore, it is simpler to use the network created locally and cultivate the trust of the people involved, aiming for a greater success rate of implementation for the proposed framework.

It is essential to highlight that this framework aims to include a combination of factors in surface water regulatory thresholds; however, factors related to groundwater, drinking water, and soil quality are not considered in this preliminary proposal.

3.1.4. Consultation of Preexisting Studies and Reports

Regulatory agencies can require environmental studies as part of environmental licensing for various industries, businesses, and land uses [20,21]. The studies aim to guide these agencies on the expected impacts and the environmental liabilities that might be brought to the region [20,21]. Depending on the size and relevance of the proposed activity, the influence area can be a few kilometers from the site, include the whole watershed, or have much larger influence areas such as ports.

Usually, third-party companies are hired for the elaboration of these studies, and the regulatory agencies evaluate the quality and verify whether all the essential topics are covered [21]. After being approved, the document is revised by various professionals with diverse backgrounds, which enriches the document and enhances its credibility. Therefore, these studies contain detailed information on different aspects of the influence area including fauna, flora, geomorphology, pluviometry, fluviometry, biomes, land use and occupation, and the presence of traditional communities such as autochthonous, indigenous or quilombolas (afro-Brazilian rural communities) that usually are more at risk and perceive contamination first due to their close ties to the water resources as a food source [21].

Avoiding contamination at its source is usually achieved by demanding that the industries perform effluent toxicity tests with the whole effluent, and the results are not above a certain threshold [21]. These assays are performed with more than one species, usually in at least two trophic levels (the most commonly used are algae or marine bacteria and daphnids). However, the results of such tests are not publicly available, meaning that there is a specific frequency at which whole-mixture toxicity is assessed, and the results are usually only used by lawmakers to attest to compliance with the law.

We propose a consultation of all environmental studies conducted on the analyzed watershed through environmental agencies, including implementation or construction studies, as well as a review of the entire mixture toxicity tests, accompanied by a list of all source chemicals used in the process. This could mean that with a database large enough to perform modeling techniques such as Adverse Outcome Pathways (AOP), the toxicity could be more easily understood, and highly toxic chemicals could be reduced at the source.

The two data sources proposed in the section do not demand the implementation of monitoring techniques or expensive equipment. This methodology is proposed to enable countries to apply it easily without an extensive monitoring network by utilizing generated data. The challenge of this crucial step is to encourage companies to make their data on toxicity public. Although it could increase the population’s trust in the regulatory agency, companies may reduce their participation due to an unwillingness to cooperate. Working on the integration of industries for environmental preservation further pushes the SDG (12) responsible production.

3.1.5. Chemical Route

After creating a database that combines the entire mixture of toxicity data with a list of all the compounds used during the process, it becomes easier to understand which compounds contribute primarily to the observed toxicity. The input data for the database should be accessible to policymakers and the public, following the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles of open data [22]. With open data, new research could emerge from evaluating the mixture toxicity on a chemical level by modeling with other software, such as Quantitative Structure–Activity Relationship (QSAR) [23], thus promoting a regulatory gain and a scientific increase in knowledge about mixture toxicity.

The mixture toxicity assays include the component-based approach or the whole mixture approach. The first means that each compound present in the mixture is tested in isolation and then in the mixture, and the latter means that the effluent is tested as a whole. The toxicity is the primary outcome of the analysis, not necessarily the chemical interaction between the parts of the mixture. Regardless of complexity, toxicity is usually caused mainly by ten compounds [17], which could mean that a priority list of compounds from each watershed could be developed. This list should also be integrated with other watchlists for emerging contaminants, such as the European watchlist.

With a finite number of compounds to be evaluated and validated by the watchlist of the region, it is possible to try to model their biochemical interactions on the species present in the watershed with methods such as AOP [24]. AOP is a modeling technique comprising a mechanistic approach to toxicity, in which the toxic pathway is separated into different vital events that could be compared with each other since they are non-species specific [25]. That means that a part of the mixture toxicity could be understood by using AOP to extrapolate some toxic effects amongst species from the closest phylogenetic group possible [25]. This would mean that if an AOP is developed for D. magna, but only Daphnia pulex is identified in the watershed, a simplification could be made, assuming these organisms have sufficient biological similarity, so that the D. magna AOP could be regionalized to D. pulex. It is worth noting that AOP tool is data intensive, thus, there might be cases in which the AOPs need to be complemented with further literature research.

3.1.6. Biological Route

Consulting the environmental studies for the watershed being analyzed, it is possible to identify the organisms susceptible to harm from chemical pollution and those that could be endangered species. Elaborating a list of the species present in the watershed could help policymakers prioritize certain species during the modeling step of the framework [26]. Using the list could also help prevent further damage if, after some research, it is discovered that certain species are susceptible to the chemicals used in the watershed. Before any modeling application, the use could be reduced, or the effluent treatment could increase its efficiency.

Discovering the sensitivity of the species present through literature research is typically how biological data is incorporated into regulations for surface water. Data on single compound toxicity is widely used, mainly when extracted from databases such as ECOTOX from the USEPA. However, to increase confidence in environmental protection, regulatory bodies could start applying methods such as the Species Sensitivity Distribution (SSD) that are more robust and include several species in the analysis [26].

SSD consists of listing as many toxicity values as possible for single compounds and ordering them from the most sensitive to the least sensitive species in a given endpoint, usually the LC50 for mortality or EC50 for immobility [26]. From this graph, a safe concentration for 95% of the species (HC5) can be extracted, thus simplifying the species-by-species analysis. Including as many species as possible increases the confidence of the method; however, it can be challenging to find information on several species in the same compound. Sala et al. [26] demonstrate that there is no statistically significant difference between SSDs of 9 to 10 species and 92 species, which means that for regulatory purposes, ten species could suffice to start the evaluation. It is also worth noting that SSDs with a small number of species (<5 species) might result in an underestimation of the HC5.

Therefore, this framework proposes elaborating an SSD curve for the prioritized compounds and using the prioritized species to regionalize the SSD for each watershed. In cases where data on the toxicity of chemicals for those species is sparse, an SSD for another chemical with a similar mode of action could be applied, using the same hypothesis as Sala et al. [26]. The authors state that if the mode of action is similar between chemicals, their toxicological effects are comparable; thus, the slope of the curve can be used as an approximation, allowing classes of organisms to be placed similarly.

Another proposition would be to use SSDs for different classes of chemicals instead of the isolated compounds, meaning that with data from the standard species alone, it could be possible to develop an SSD [26]. Integrating read-across methodologies could increase the number of species by adding new taxonomically similar species [27]. Those values could serve as a guideline to policymakers on a low-data scenario since data on the toxicity of organisms such as daphnids, algae, or trout are usually available [26]. Regulatory bodies demand this toxicity information, and thus, it is more widely accessible.

3.1.7. Social Route

Among the main studies and documents elaborated at the watershed level, watershed management plans are some of the most important, as they can be consulted to benefit from the network of stakeholders that these plans contain. Part of these documents list the main land uses and industries present in the region and their impacts on the water resources. Usually, watershed management plans consult the local communities to ensure that all involved parties are heard [28].

Civil society could play a key role in reporting the impacts of chemical pollution to the authorities, through actions such as recording and documenting environmental alterations, e.g., a decline in fish populations, visibly changing water properties (such as color and turbidity), or reporting cases of new diseases caused by pollution. The latter should also be consulted with data from the departments of the region responsible for tracking epidemiological data, such as the health surveillance department, environmental monitoring agency, or any department that gathers toxicity data from the compounds used in the watershed.

Consulting with traditional local communities, such as autochthones, indigenous groups, or quilombolas, is a crucial step in reducing the distance between all stakeholders and the people whose livelihoods may be significantly affected by chemical pollution. Including these communities at the elaboration stage could reduce the damage caused by environmental racism, which is a recent definition for the centuries-old problem of marginalized communities experiencing more significant environmental impacts than their non-marginalized counterparts.

Integrating the watchlist of chemicals and their potential adverse effects using AOP could help health departments and hospitals track health records and relate the data to water quality. Thus, all the proposed routes are interconnected and would help one another in reinforcing protection.

3.1.8. Regulation Updating

Integration between routes is the primary key of the proposed framework, since it is already known that one of the problems in environmental regulation is how distant regulatory bodies can be from each other, given that there are several possible exposure routes for humans and biota [18]. Those regulatory silos [18] are one of the challenges in creating an environmental regulation that could be easily updated and thus realistically protect the environment.

Alternatives to further include mixtures in the regulation have already been discussed, and one of the most promising ones is the Mixture Assessment Factor (MAF) [2]. This methodology involves creating a factor to adjust current regulations to natural environment scenarios that include multiple compounds co-occurring in the same body of water. The proposed factor could serve as a transitional stage between the current moment and the future. We could better integrate modeling with regulatory practices and further protect the environment by using more accurate data on physical and biochemical processes.

Drakvik et al. [2] stated that the MAF could be based on different aspects considered essential for the region. It could be based on synergism already observed in the literature; for example, it was observed that diclofenac and sulfamethoxazole have a synergistic effect (observed effect greater than the additive effect), and the authors calculated a mixture toxicity index of 3.29 for the effect of these compounds on the mortality of Eusenia fetida [29]. Thus, if the regulators chose this parameter as their MAF, the regulatory thresholds for both these compounds could be corrected 3.29 times to reduce this effect.

Climate change is also currently altering the effects of pollutants on the environment by changing their characteristics of exposure, uptake, and metabolization [30]. Parameters such as bioavailability and organism sensitivity are being altered by not only the temperature but also the ocean acidification [30]. These are topics that can enhance the advancements sought by the SDG (6) clear water and sanitation, (13) climate action, and (14) life below water.

3.2. Connections Between Academia, Regulatory Bodies, and Industry

Greater integration between all stakeholders is needed to implement the proposed framework efficiently, given that it applies new concepts and methodologies relevant to academia, regulatory bodies, and industry. Therefore, to increase the likelihood of the application’s success, we propose the creation of a workgroup to provide guidance and feedback on how to utilize the proposed methodology and how it can be improved. This workgroup would comprise scientists, policymakers, and industry professionals to better convey knowledge to each stakeholder.

First, contact could be made through the watershed committees or similar structures, since they are the groups responsible for including all relevant stakeholders regarding surface water quality. Profiting from previous efforts makes it easier to implement any new proposed methodology. The primary method to diffuse the framework to interested parties would be through elaborating courses, seminars, and workshops promoted by interdisciplinary groups of experts from different organizations and scientists. Groups such as ICLEI already tackle bridging this gap by promoting activities with policymakers, e.g., workshops on contaminants of emerging concern and river-specific pollutants.

Workshops would promote a greater understanding of mixture toxicity and associated risks and explain how the proposed framework could be integrated into the current workflow by teaching how to use the New Approach Methodologies integrated in this paper. It is essential to highlight a feedback section to include all stakeholders’ opinions on the implementation stage.

3.3. Framework Limitations and Future Work

The proposed framework has some limitations, and they are as follows.

Currently, the framework cannot include in its evaluation pollutants without defined regulatory thresholds, such as macro, micro, or nanoplastics. Therefore, other pollutants without a water quality standard will also not be able to be included. The solution to this question would be to rely on other water quality threshold definitions to first define a threshold and then update it with the method presented here.

Limitations concerning feasibility barriers are related mainly to the costs of the workshops proposed and laws regarding the data availability from industries in cases which local data privacy laws might pose a delay in the accessibility of regulators. The effort to convince industries to feed these databases with toxicological data should also be considered as it is one of the key concepts for this framework.

4. Conclusions

New emerging scenarios, such as chemical pollution and climate change, are demanding greater adaptations from all sectors for sustainability and environmental protection, especially in the Global South. To address these issues, this paper creates a sustainable framework that integrates a few different methodologies that converge to promote environmental quality standards closer to actual environmental conditions, since no single methodology can fully encompass all subjects into regulation.

The innovation associated with this sustainable framework proposition is related to its integration between different sectors, like the biological, social, and environmental routes. These were considered the most relevant factors for environmental regulation due to their relevance to the regulatory steps. The biological and chemical routes are connected to a greater extent due to their conceptual connection, especially in environmental toxicity data. This highlights that countries that do not have access to extensive research could use data generated by other sources and still have a safer environment with a data-based analysis.

However, most frameworks do not include the social route, even though it is an essential aspect of the success rate of any policy. Including the participation of civil society and marginalized communities in the conversation could also increase the sense of belonging and importance to otherwise forgotten communities and thus start a positive feedback loop with more engagement and knowledge from every part involved.